💬In plain words
What the trial is, and whether it could suit you
This randomized cross-over pilot clinical trial aims to evaluate the feasibility and effect of a relaxing virtual reality (VR) experience on glucose response after white bread consumption, compared to a stress-inducing VR, a VR clinical room, and a real clinical room, in healthy adults. Participants will use a head-mounted display to experience either one of the VR environments, or they will simply sit in an actual clinical room for 15 minutes. After this pre-meal condition, participants will consume 66 grams of white bread within 10 minutes, accompanied by 250 mL of water. They will then continue their assigned pre-meal condition for one hour, followed by an additional hour of sitting in the lab for further assessments.
The feasibility of the study will be assessed by calculating: 1) Screening to randomization ratio, 2) Recruitment rate of participants per week, 3) Retention rate, 4) D
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Participants must meet all of the following criteria to be eligible for the study:
1. Aged between 18 and 50 years, of any sex.
2. Body mass index (BMI) between 18.9 and 29.9 kg/m².
3. Fasting blood glucose between 3.5 and 5.6 mmol/L.
4. They typically consume breakfast as part of their regular routine.
5. Willing and able to provide written informed consent.
6. In the opinion of the Investigator, the participant is capable of understanding and adhering to all study requirements.
Participants will be excluded if they meet any of the following conditions:
1. Fasting blood glucose ≥ 5.6 mmol/L or \< 3.5 mmol/L.
2. Medical conditions that contraindicate the use of virtual reality (VR) headsets, including panic disorders, seizure disorders, migraines, certain vision impairments, or VR-related motion sickness.
3. A history of allergy or adverse reaction to white bread.
4. Current adherence to a special diet or use of supplements/medications that may affect carbohydrate metabolism, heart rate, or the nervous system within the last 6 months.
5. Medical history of hypertension, HIV/AIDS, hepatitis, type 1 or type 2 diabetes, cardiovascular or pulmonary diseases, or gastrointestinal disorders impacting carbohydrate metabolism.
6. Major physical injury or surgical procedure within the last 3 months.
7. Participation in any other randomized controlled trial within the previous 3 months.
8. Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
9. Being unable to consume the test meal within the required 10-minute timeframe.
10. History of cancer within the past two years, excluding non-melanoma skin cancers.
11. Current or recent (within 12 months) excessive alcohol use defined as more than 14 standard drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz spirits).
12. Significant weight change (gain or loss exceeding 3.5 kg) in the past 3 months.
13. Inability to provide written informed consent.
💊
What it tests
- A relaxing VR environment
- A stress-inducing VR game
- A VR clinical room
- A non-VR clinical room
University of Manitoba
Winnipeg, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky